December 2014 FDA Recall Fluconazole by Baxter Healthcare Corp.
D-0380-2015 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on December 23, 2014 for the product Fluconazole. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0380-2015

Reason for Recall
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Initiated
12-23-2014
Reported
02-04-2015
Quantity
31,130 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70057
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, United Arab Emirates, and Columbia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-21-2016
Product Description About Product Description
Full technical description of the product.
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.

Batch or Lot Expiration Information

Lot# : P318394; Exp 05/31/16

Affected Packages Involved in this Recall

0338-6046-48 Fluconazole
0338-6045-37 Fluconazole